BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFUSOR

    MDR report key: 10338837 · Received July 29, 2020

    Report

    Report Number
    9610825-2020-00161
    Event Type
    Death
    Date Received
    July 29, 2020
    Report Date
    July 29, 2020
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN REQUESTED TO SEND IT FOR INVESTIGATION TO (B)(4) LABORATORY IN (B)(4). AS NO SAMPLE AND NO PICTURE WAS PROVIDED FOR INVESTIGATION A MALFUNCTION COULD NOT BE DETECTED AND THEREFORE THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. THE COMPLAINT IS ONLY TAKEN TO KNOWLEDGE AND FILED FOR STATISTICAL PURPOSES. HOWEVER, IF THE COMPLAINT SAMPLE WILL BE PROVIDED, THE COMPLAINT WILL BE RE-OPENED ACCORDINGLY. AN INVESTIGATION WAS INITIATED BY THE PUBLIC PROSECUTOR AND THE DEVICE WAS CONFISCATED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY IN (B)(6): "OPERATING UNIT, FAULTY FUNCTION." CUSTOMER INFORMATION: ONE PATIENT WAS SEDATED WITH THE ANESTHETIC GAS SEVOFLURANE VIA A SYSTEM. AN ANALYSIS IN THE SYSTEM SHOWED THAT THERE WAS A SIGNIFICANT DROP IN GAS CONCENTRATION IN THE LAST 15 MINUTES. A TECHNICAL DEFECT OF THE DEVICE CANNOT BE EXCLUDED. AT THIS POINT, 4 PERFUSOR SPACE SYRINGE PUMPS WERE PROBABLY INVOLVED. NO DATE OF OCCURENCE (DATE OF DEATH) WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805912 PERFUSOR PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Death